510(k) · Cleared
ClearedIce Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ulike Smart Electronics Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Sep 9, 2024 as substantially equivalent to K221002 (Shenzhen Ulike Smart Electronics Co., Ltd., 2022) and 1 other predicate after a 132-day review. Its family tree reaches back 23 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 9, 2024
- Review
- 132 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K950019 (1995). 65 ancestors in all, the oldest K892514 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 23 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 19 generations between
- 3 generations backK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
- 2 generations backK220248 Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022
- 1 generation backK240264 Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
- This deviceK241205 Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK250171 IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252618 IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co., Ltd. · 2025
Show all 23 generations
- Root · 23 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 22 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 21 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 20 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 19 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 18 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 17 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 16 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 15 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 14 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 13 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 12 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 11 generations backK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- 10 generations backK123845 MESyneron Beauty, Ltd. · 2013
- 9 generations backK131649 MESyneron Beauty, Ltd. · 2013
- 8 generations backK143003 iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited · 2015
- 7 generations backK160968 iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited · 2016
- 6 generations backK161428 PerfectSmoothShen Zhen Cosbeauty Co., Ltd. · 2017
- 5 generations backK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- 4 generations backK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- 3 generations backK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
- 2 generations backK220248 Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022
- 1 generation backK240264 Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D…Shenzhen Mlay Intelligent Technology Co.,, Ltd. · 2024
- This deviceK241205 Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU…Shenzhen Ulike Smart Electronics Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −22 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −21 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −20 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −19 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −18 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −17 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −16 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −15 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −14 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −13 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −12 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −11 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| −10 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −9 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| −8 | K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | 2015 | — |
| −7 | K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | 2016 | — |
| −6 | K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | 2017 | — |
| −5 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| −4 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| −3 | K210311 | Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B… | Shenzhen Mismon Technology Co., Ltd. | 2021 | — |
| −2 | K220248 | Home use hair removal device | Shenzhen Mareal Tech Co., Ltd. | 2022 | — |
| −1 | K240264 | Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A… | Shenzhen Mlay Intelligent Technology Co.,, Ltd. | 2024 | — |
| 0 (this device) | K241205 | Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024 | — |
| +1 | K250171 | IPL Hair Removal Device (BE965A, BE965B, BE965C) | Shenzhen Yang WO Electronic Co., Ltd. | 2025 | — |
| +2 | K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OHT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OHT device
- #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221002 | IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CSummary page 6…Predicate Device 1 Predicate Device 2 510(k) number K241205 K221002 K240264 Trade Name Ice Cooling IPL Hair IPL Hair Removal Home use hair… | 2022 |
| * | K240264 | Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…Summary page 6…Predicate Device 2 510(k) number K241205 K221002 K240264 Trade Name Ice Cooling IPL Hair IPL Hair Removal Home use hair Removal Devic… | 2024 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250171 | IPL Hair Removal Device (BE965A, BE965B, BE965C) | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 17 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 65 ancestors has a recall of any class.
- Of its descendants, K250171 (Shenzhen Yang WO Electronic Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K221002.
How does its category compare?
All OHT devicesOHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OHT
25in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHT
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHT
No recall names OHT since 2007.
Adverse event reports per year · OHT
6in 2025
MAUDE reports naming product code OHT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 81 | 0 | 2 |
| 2017 | 6 | 87 | 0 | 0 |
| 2018 | 8 | 89 | 0 | 0 |
| 2019 | 7 | 64 | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 12 | 89 | 0 | 1 |
| 2022 | 25 | 70 | 0 | 2 |
| 2023 | 32 | 83 | 0 | 6 |
| 2024 | 26 | 62 | 0 | 0 |
| 2025 | 25 | 87 | 0 | 6 |
| 2026 | 11 | 84 | 0 | — |
What is it indicated for?
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241205: Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241205
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026